COVID drug Trump got in high demand
When Dora Mendez tested positive for the coronavirus Aug. 20, she was surprised.
Mendez, 50, is fully vaccinated. But the Redwood City resident had a kidney and pancreas transplant 19 years ago and takes medication that suppresses her immune system, which may have interfered with her body’s ability to build up protective antibodies
After she tested positive, her doctor quickly referred Mendez to a Stanford Medicine clinic that administers monoclonal antibodies to eligible COVID patients. Monoclonal antibody therapy is the only treatment authorized for nonhospitalized patients with mild or moderate symptoms in early stages of the disease. The drug made headlines last year after former President Donald Trump received it.
It was not widely used for many months but is gaining traction now, as the delta surge drives
new infections and the need for treatment.
Mendez’s status as a severely immunocompromised solid organ transplant recipient made her a good candidate for the treatment, and by Wednesday, she was getting the roughly 40-minute IV infusion at a clinic in Palo Alto. On Thursday, she said the mild symptoms she’d been experiencing, a loss of smell and taste, seemed to be improving and she felt well while quarantining at home.
Mendez is one of a growing number of Bay Area residents who in recent weeks have received monoclonal antibodies to prevent their COVID-19 symptoms from worsening. The therapy is becoming more in demand as doctors and patients are gaining awareness of its availability, as more doses are being shipped to providers around the country, and as federal regulators expand eligibility for who can get it. The clinic that treated Mendez has seen referrals for monoclonal antibodies skyrocket in the past four weeks, from two referrals a day to more than 30, said Stanford’s Dr. Upinder Singh, who oversees the clinic.
The growing availability of the treatment comes at a welcome time. COVID will probably be around in some form for years. And as long as there are people who are unvaccinated or unable to mount an immune response to a vaccine, they are vulnerable to the worst outcomes and will need treatment. While there are two other approved therapies —the antiviral remdesivir and the steroid dexamethasone — both are typically given to hospitalized patients only.
“Giving (patients) a therapy offers them hope,” said Dr. Jeanne Noble, director of COVID response at UCSF’s Parnassus emergency department, which administers monoclonal antibodies to overflow patients whom UCSF’s outpatient clinic can’t accommodate. “We’re not in a situation (like that of ) early in the pandemic when we had almost nothing to offer. Now we have a therapy that has good data behind it and it’s quite effective.”
The most widely used monoclonal antibody treatment in the U.S. is made by Regeneron Pharmaceuticals, a New York-based biotechnology company. It is a combination of two drugs, casirivimab and imdevimab, given by IV or injection. It gives the body synthetic antibodies that mimic those the body would have produced on its own after vaccination. The antibodies bind to the virus’ spike protein and block the virus from infecting human cells.
The FDA granted emergency use authorization to the Regeneron drug, and a similar Eli Lilly drug, in November. But they were not widely used during the winter surge, in part because hospitals struggled to administer the treatment during staffing shortages. The Lilly drug was halted after it was found to be less effective against variants. Regeneron is the only monoclonal antibody treatment that the federal government is providing free to providers, so it’s what most medical centers are currently using.
The Regeneron drug reduces risk of hospitalization and death by 70%, according to the company’s clinical trial data. Local doctors who have treated patients report promising results as well.
“We have seen very few patients who’ve received Regeneron who’ve needed subsequent hospitalization,” said Noble of UCSF. “Anecdotally, it seems to be working well.”
This is critical to help ease the burden on hospitals, many of which are filling up again amid the delta surge.
“An ounce of prevention is worth a pound of treatment,” Dr. Manisha Israni-Jiang, who last year helped launch the
monoclonal antibody program for UCSF outpatient clinics. “The reason we need to make the most of (monoclonal antibody) treatment is it’s preventing hospitalization.”
The treatment is not meant for everyone. It’s limited to patients like Mendez who are immunocompromised and at highest risk of progressing to severe disease. Patients who are at high risk for other reasons are also considered good candidates, such as those over 65, those over 55 with comorbidities like obesity and diabetes, and pregnant women. Patients must be 12 or older and weigh at least 40 88 pounds, under the FDA’s guidelines.
And it must be given within the first 10 days of symptoms and only if symptoms are mild or moderate.
It’s hard to quantify the regional supply and demand for the drug. But providers say they are busy. The UCSF outpatient clinics that do the infusions are “pretty much booked up every day,” Noble said, with the emergency department doing the treatment for the clinics’ overflow patients at least a few times a week.
In August, UCSF’s emergency department treated 54 patients with the infusions, the most in a given month since the pandemic began — up from 32 in July and three in June. It was also one of the few medical sites that were regularly doing the infusions during the winter surge, treating 35
patients in December and 44 January.
About 730,000 people in the U.S. have received the Regeneron treatment, according to the U.S. Department of Health and Human Services, which distributes the drug to providers. The agency did not provide figures for each state.
More than 40 providers in the Bay Area have received the Regeneron drug, according to the Health and Human Services Department, though not all of the providers administer it on a regular basis. UCSF and Stanford are among those that do, and both have opened up access to the medicine to patients outside of their health systems.
Patients can ask their doctor to refer them, or do a self-referral. UCSF, for instance, has a referral system that asks patients to fill out their qualifying criteria and directs them to a virtual visit that will assess their eligibility.
Regeneron did not specify how many doses have gone to Bay Area providers. Nationally, though, the company is fielding more orders as cases continue soaring. Since mid-July, the number of doses Regeneron has shipped has grown sixfold from 25,000 doses a week to 150,000.
Most of the orders are coming from Southern states, where the U.S pandemic is the worst. Between July 1 and Aug. 22, 78% of the roughly 500,000 courses ordered by 4,000 U.S. providers came from 13 states: Kentucky, Tennessee, Mississippi, Alabama, Georgia, Florida, South Carolina, North Carolina, New Mexico, Texas, Oklahoma, Arkansas and Louisiana.
Regulators are expanding who can get Regeneron. On Aug. 10, the FDA said the drug can be used as a post-exposure preventive measure for highrisk individuals. This means some people who’ve been exposed to a person with a known COVID infection can take it, even if they have yet to test positive or show symptoms. This opens the door to helping prevent COVID, not just treating the symptoms, for a critical group.
This, too, is limited to those at highest risk, including people who are not fully vaccinated or are immunocompromised, who have been exposed to someone with COVID in the past seven days.
“That’d be good for nursing homes, or patients with cancer whose spouse gets COVID,” said Singh, of Stanford.
And for those, like Mendez, who are lucky enough to have gotten it, there’s palpable relief.
Mendez said she was “very worried” when she found out she had COVID because of her vulnerability, but said that the treatment helped ease her concerns.
“I feel good that I got it,” she said. “I think it helped me a lot.”